Repeats as part of investigations, ja oder nein? [BE/BA News]
Thanks Ohlbe,
for this document.
Now a million dollar question:
Are you on basis of the wording on page 13 allowed to do a repeat analysis as part of an investigation? Is for example absent or low IS response (without obvious poor chromatography) itself an assignable cause? If it is, then that would negate the need for an investigation, right?
If taken literally I am inclined to think the guidance does not allow repeats as part of investigations (to me, investigations are done when root causes are not known but potential root causes are being sought).
Common sense takes me a bit in the opposite direction and I would any day prefer to talk about reported repeats and unreported repeats on basis of the presence of a cause.
❝ The FDA have just published their revised guideline on bioanalytical method validation.
for this document.
Now a million dollar question:
Are you on basis of the wording on page 13 allowed to do a repeat analysis as part of an investigation? Is for example absent or low IS response (without obvious poor chromatography) itself an assignable cause? If it is, then that would negate the need for an investigation, right?
If taken literally I am inclined to think the guidance does not allow repeats as part of investigations (to me, investigations are done when root causes are not known but potential root causes are being sought).
Common sense takes me a bit in the opposite direction and I would any day prefer to talk about reported repeats and unreported repeats on basis of the presence of a cause.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- New FDA BMV guideline Ohlbe 2018-05-21 16:28 [BE/BA News]
- What a monster! Helmut 2018-05-21 17:47
- What a monster! jag009 2018-05-24 03:19
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-29 18:13
- What a monster! jag009 2018-05-24 03:19
- Repeats as part of investigations, ja oder nein?ElMaestro 2018-05-22 00:17
- Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
- Requirements ⇒ recommendations Helmut 2018-08-01 11:12
- Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59
- Requirements ⇒ recommendations Helmut 2018-08-01 11:12
- Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
- Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
- What a monster! Helmut 2018-05-21 17:47